Federal Circuit Halts Market Launch of the First U.S. Biosimilar

Fitzpatrick Case Update
May 12, 2015

On May 5, 2015, the Federal Circuit issued an Order preventing Sandoz from launching its biosimilar drug, Zarxio® in the United States, pending a decision on Amgen’s motion for a preliminary injunction. Despite being FDA approved on March 6, 2015, Zarxio® will now not enter the market until later this year, at the earliest.

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